Woodhead Publishing Series in Biomedicine

1 primary work

Process Validation for the Production of Biopharmaceuticals

by Dr. Anthony R. Newcombe and Dr. Piranavan Thillaivinayagalingam

Published 1 October 2012

Process validation for the production of biopharmaceuticals examines the practical, theoretical and regulatory aspects of process validation relevant to biopharmaceutical production and critically evaluates individual manufacturing unit operations. Chapters provide validation solutions applicable to a variety of commercial biopharmaceutical processes. The text includes a description of validation strategies and aspects of regulatory compliance with industry-focused practical examples. This book considers risk management strategies used for the selection of critical and key process parameters, along with the methodology used to categorise process outputs and define validation acceptance criteria.